Kornimate/medical-research-clean huggingface dataset:
the postoperative radiotherapy in n1 breast cancer patients

Conditions: Radiotherapy; Breast Cancer

Summary: this study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (pmrt)/whole breast irradiation plus regional radiotherapy (wbi+regional rt) versus and no pmrt/wbi alone group. this is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.

1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (bcs) versus mastectomy) and the type of histologic type (triple negative breast cancer (tnbc) versus non-tnbc) the control group: * if patients received bcs, wbi+regional rt * if patients received mastectomy, pmrt the experimental group: * if patients received breast conserving surgery, wbi alone * if patients received mastectomy, no pmrt

Eligibility criteria:
inclusion criteria: * patients aged 19 years or older. * a female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer. * patient with stage pn1 after surgery on histopathologic examination. * however, if mastectomy was performed, 5 or more nodes should be resected in the case of 1 positive node, and axillary lymph node dissection (alnd) should be performed in case of 2 or 3 positive nodes. * patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive. * patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(her)-2 positive. * patients with eastern cooperative oncology group (ecog) scale 0-2. * patients who agreed to participate in the study. exclusion criteria: * patients who have received prior \[neoadjuvant\] chemotherapy. * patients receiving radiation therapy for salvage or palliative purposes. * patients with stage t4. * patients with ipsilateral supraclavicular and internal mammary lymph node metastases or distant metastases. * male breast cancer patient. * patients who have previously received radiation therapy to the ipsilateral breast or supraclavicular region. * patients having a history of cancer other than thyroid cancer, cervical carcinoma in situ, or skin cancer. * patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or benign tumors based on histological diagnosis.

Keywords: breast cancer radiotherapy omission breast conserving surgery mastectomy tnm pathologic stage n1
treatment of chronic fatigue syndrome and fibromyalgia with d-ribose- a multicenter study

Conditions: Fibromyalgia; Chronic Fatigue Syndrome

Summary: to determine whether adding ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with cfs and/or fibromyalgia (cfs/fms).

chronic fatigue syndrome and fibromyalgia (cfs/fms) are debilitating syndromes affecting \~ 2-4% of the population. although they are heterogeneous conditions associated with many triggers, including infections, autoimmune illnesses, hormonal dysfunctions and other processes, they appear to have the common pathology of being associated with impaired energy metabolism. as d-ribose has been shown to increase cellular energy synthesis in heart and skeletal muscle, and was shown to significantly improve clinical outcomes in cfs/fms in an earlier pilot study, we conducted a larger, community based, multicenter trial to see if these findings could be generalized to a broader patient population. we hypothesized that giving d-ribose would improve function in cfs/fms patients.

Eligibility criteria:
inclusion criteria: * diagnosed with fibromyalgia (fms) (by american college of rheumatology \[acr\] criteria) and/or chronic fatigue syndrome (cfs- by centers for disease control \[cdc\] criteria) by a health practitioner. exclusion criteria: * pregnant or nursing women, or * any participants with known severe medication or nutrient sensitivities, or * previous ribose use.

Keywords: fibromyalgia chronic fatigue syndrome d-ribose fatigue
treatment of cirrhosis-related hepatocellular carcinoma with the intrahepatic arterial injection of an emulsion of lipiodol and idarubicin (zavedos®): phase i study

Conditions: Unresectable Non-metastatic Hepatocellular Carcinoma; Child A/B7 Cirrhosis

Summary: unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (hcc) has a poor prognosis as there are no recommended curative treatments. chemoembolisation is the most widely used treatment in these patients, but this technique can prove to be toxic. intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective therapeutic approach, without deteriorating liver function. the rationale for this treatment can be resumed as follows: * hcc are vascularised via the hepatic artery system * the iha perfusion of anthracyclines leads to high elimination via the liver with low systemic concentrations * the absence of embolisation reduces toxicity * the toxiciity profile of idarubicin is well known and the drug is widely used for the iv treatment of leukemia * idarubicin is the most cytotoxic drug for tumor cell lines. * the in vitro cytotoxicity of idarubicin is 100% at low concentrations * lipiodol can stay in contact with tumor tissue for several weeks after injection and act as a vector for the drug * the idarubicin-lipiodol is more stable than lipidol emulsions usually given by intraarterial injection * the emulsion is more stable with idarubicin than with other anticancer molecules * sequential inclusion in accordance with the "continual reassessment method" makes it possible to increase inclusions at a target toxicity level while reducing inclusions at doses that are too low or too toxic the aim of the treatment is to improve survival.


Eligibility criteria:
inclusion criteria: histologically-proven hepatocellular carcinoma or carcinoma meeting validated non-invasive criteria (easl, aasld) * child-pugh a or b7 cirrhosis * general health status who 0.1 * platelets \> 50 000/mm3, polynuclear neutrophils \> 1000/mm3 * creatininemia \< 1.5 times upper limit of normal * lvef by muga scan or us \> 50 % * age \> 18 years * signed informed consent * for women child-bearing age, an effective means of contraception exclusion criteria: patients who can benefit from curative treatment (surgical resection, liver transplant or treatment via percutaneous destruction) * non-cirrhotic liver * cirrhosis child b8 or b9 or c * extrahepatic metastases (pulmonary micronodules \< 7mm are not considered a contra-indication) * digestive hemorrhage within the previous month * patient on anticoagulants * pregnant women * uncontrolled infection * hypersensitivity to anthracyclines * hypersensitivity to iodine contrast agents * patient under guardianship or ward of court * patients who have already received the recommended cumulative dose of anthracycline (93 mg/m2 for idarubicin, 140 mg/m2 for mitoxantrone, 550 mg/m2 for doxorubicin, 600 mg/m2 for daunorubicin, 900 mg/m2 for epirubicin)
early progressive feeding in human-milk fed extremely preterm infants: a randomized trial

Conditions: Premature; Infant, Light-for-dates

Summary: to test the hypothesis that progressive feeding without minimal enteral feeding (mef) compared to progressive feeding preceded by a 4-day course of mef will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.

qualifying participants will be randomly assigned to one of two study groups: 1) early progressive feeding without mef or 2) progressive feedings preceded by 4 days of mef. regardless of study group assignment, donor human milk will be offered if not enough of the mother's expressed breastmilk during the intervention phase of the trial. intervention group: progressive feeding of 20-24 ml/kg/d on day 1 of feeding, followed by daily increments of 24-25 ml/kg/d as tolerated until full enteral feeding achieved. control group: mef with feeding volumes of 20-24 ml/kg/d for 4 days followed by progressive feeding (daily increments of 24-25 ml/kg/d) as tolerated until full enteral feeding achieved. both groups will receive fast progressive feeding (\>/= 24 ml/kg/day) if parent agrees, stool "dirty" diapers will be collected 5 times (at birth, 1, 2, 3 and 4 weeks of life).

Eligibility criteria:
inclusion criteria: * admission to the nicu within 48 hours with gestational age between 22.0 and 28.6 weeks exclusion criteria: * small for gestational age (\<10th percentile birthweight), major congenital or chromosomal anomalies, and infants with terminal illness in which decision to withhold or limit support have been made

Keywords: premature infant early progressive feeding
successful control and clinical effectiveness of seretide(salmeterol/fluticasone propionate) study in asthma.(success)

Conditions: Asthma

Summary: the primary study objective is to demonstrate the clinical effectiveness of seretide therapy compared to the current care in management of moderate to severe persistent asthma patients in korea.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 years and over who are willing to give a written consent to participate in the study. * subjects with a documented clinical history of reversible airways obstruction (history taking is acceptable) for at least 12 months and, in the opinion of the investigator, is able to comply with therapy and to complete the daily record cards (drcs) correctly. * subjects able to demonstrate the ability to effectively (physically and/or mentally) use a diskus (a dummy diskus provided for test). * a female is eligible to enter and participate in this study * subjects with access to telephone (mobile or landline at home) exclusion criteria: * previous use of ics /laba combination inhaler (symbicort (astrazeneca) or seretide) 12 weeks prior to visit 1. * subjects with known or suspected hypersensitivity to inhaled steroids or beta2-agonists. * subjects who have had other changes in their regular asthma medication within 2 weeks of visit 1. * subjects who have had a lower respiratory tract infection within 4 weeks of visit 1. * subjects who have a smoking history of 10 pack years (e.g. 10 cigarettes/day for 20 years or 20 cigarettes/day for 10 years or 40 cigarettes/day for 5 years) or more at the time of visit 1 (current smoker can be included even if his/her smoking history is less than 10 pack years at the time of visit 1). * subjects who suffer from serious, uncontrolled diseases (including serious psychological disorders) likely to interfere with the study. * subjects who are on immunotherapy * subjects who have taken any investigational drugs within 4 weeks of visit 1. * subjects who have, in the opinion of the investigator, evidence of alcohol or drug abuse. * females who are pregnant, lactating or are of child bearing potential and are likely to become pregnant. females of childbearing age may be included if, in the opinion of the investigator, they are exerting adequate contraceptive precautions. * subjects who have previously been enrolled into this study * patients on regular oral or parenteral steroid therapy in the last 4 weeks or more than 3 courses of steroid in the last 6 months * subjects who have fev1 or pefr of less than 50% predictive value.

Keywords: seretide asthma korean act
a study of ly2127399 in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will investigate how ly2127399 works in participants with rheumatoid arthritis (ra) who are not adequately responding to methotrexate. participants will receive ly2127399 via an injection(s) under the skin at 4 week intervals for up to 52 weeks. key study procedures include biopsies of the lining of an inflamed joint and blood tests to measure ra activity.


Eligibility criteria:
inclusion criteria: * diagnosis of adult onset ra disease according to revised 1987 american rheumatism association (ara) criteria and currently have a documented history of positive for rheumatoid factor (rf) and/or anti-cyclic citrullinated peptide antibody (anti-ccp ab) and have moderately to severely active ra despite ongoing methotrexate (mtx) therapy * have active ra defined as the presence of at least 8/68 tender and at least 8/66 swollen joints, as determined by the tender joint count and swollen joint count assessment forms * have a screening c-reactive protein (crp) measurement greater than 1.2 times upper limit of normal or erythrocyte sedimentation rate (esr) greater than 28 millimeters/hour (mm/hr) * have a clinically inflamed joint suitable for synovial biopsy procedure exclusion criteria: * have used an unstable dose of non-steroidal anti-inflammatory drugs (nsaids) within 6 weeks prior to baseline * have used oral corticosteroids at average daily doses of \>10 milligrams/day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline * have received any parenteral corticosteroid injection within 6 weeks of baseline * have used other disease-modifying anti-rheumatic drugs (dmards) other than mtx, hydroxychloroquine, and/or sulfasalazine in the 8 weeks prior to baseline
a study to investigate the prevention of covid-19 withvyd222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to sars-cov-2

Conditions: COVID-19; SARS-CoV-2

Summary: a study to investigate the prevention of covid-19 with vyd222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to sars-cov-2


Eligibility criteria:
inclusion criteria: * is an adult aged ≥18 years or an adolescent aged 12 to \<18 years and weighs at least 40 kg at the time of screening. * tests negative for current sars-cov-2 infection by local antigen test or rt-pcr at the time of screening. * for cohort a, has significant immune compromise from causes including solid tumor or hematologic malignancies, chimeric antigen receptor (car)-t-cell therapy or hematopoietic stem cell transplant, primary immunodeficiency, advanced hiv infection, or receiving qualifying immunosuppressive therapies. * for cohort b, is at risk of acquiring sars-cov-2 due to regular unmasked face-to-face interactions in indoor settings. * agrees to defer receipt of any covid-19 vaccination or booster for a minimum of 28 days after dosing. * note: unless specified by cohort, the criteria apply to both cohorts exclusion criteria: * for cohort b: prior receipt of a covid-19 vaccine or booster within 120 days before randomization. * prior receipt of convalescent plasma or a mab to sars-cov-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization. * prior known or suspected sars-cov-2 infection within 120 days before randomization. * exposure to someone with known or suspected sars-cov-2 infection in the 5 days before randomization. * is acutely ill or has any symptoms suggestive of infection, in the opinion of the investigator. note 1: other protocol defined inclusion/exclusion criteria apply note 2: unless specified by cohort, the criteria apply to both cohorts

Keywords: immune compromise vyd222 sars-cov-2 monoclonal antibody covid-19 prevention
antibody levels associated with reduced risk of invasive group b streptococcus disease in infants aged less than 90 days

Conditions: Invasive Group B Streptococcus Disease

Summary: compare anticapsular antibody levels against group b streptococcus at delivery in mothers and their infants who develop disease versus those who do not. use this comparison to establish antibody levels associated with reductions in risk of gbs disease in infants aged less than 90 days.


Eligibility criteria:
inclusion criteria: * pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers. * subjects aged ≥18 years. * able to understand and comply with planned study procedures. * provides written informed consent. exclusion criteria: * refuses to consent to study participation.

Keywords: group b streptococcus early onset disease late onset disease anticapsular antibodies serotype specific
improving pulmonary hypertension screening by echocardiography

Conditions: Pulmonary Hypertension

Summary: this study aims to assess the application of the novel impulse algorithm for the detection of pulmonary hypertension (ph) in those with a low or intermediate probability of ph according to the british society of echocardiography (esc) and european society of cardiology (esc) guidelines.

this is a prospective, multi-centre cross-sectional study with a planned 18 month longitudinal component. participants will be recruited from patients referred for the first time for transthoracic echocardiography at the royal united hospitals bath national health service (nhs) foundation trust, royal free hospital nhs foundation trust, sheffield teaching hospitals, royal papworth hospital, and golden jubilee hospital. the investigators will prospectively recruit patients without a diagnosis of pulmonary hypertension. transthoracic echocardiographic (tte) imaging will be performed in line with british society of echocardiography minimum dataset guidelines, and comprehensive right heart echocardiographic imaging and analysis will be performed following the british society of echocardiography recommendations for assessing right heart function, in addition to the impulse algorithm; a right ventricular free wall longitudinal strain value of less than -23%, or, right ventricular fractional area change (fac) less than 35% in females/30% in males, in addition to a right ventricular isovolumetric relaxation time in excess of 73ms in patients with low/intermediate probability of ph by current guidelines would categorise that patient as being impulse positive.

Eligibility criteria:
inclusion criteria: * unexplained breathlessness * risk factors for pulmonary arterial hypertension (pah), chronic thromboembolic pulmonary hypertension (cteph) * unexplained elevation of b-type natriuretic peptide (bnp/probnp) * referred for catheterisation. exclusion criteria: * esc / bse echo high probability of ph * known or suspected congenital heart disease * patients unlikely to benefit from management of ph or its underlying causes.
fast antibiotic susceptibility testing for gram negative bacteremia trial

Conditions: Gram-negative Bacteremia; Bloodstream Infection

Summary: this study is a 2-arm, multicenter, multinational, prospective, randomized, controlled clinical trial. hospitalized subjects with blood cultures growing gram negative bacilli (gnb) will be randomized 1:1 to have the positive blood cultures characterized using standard of care (soc) antimicrobial susceptibility testing (ast) vs. a rapid ast method known as reveal™ in addition to soc ast. the purpose of the fast trial is to evaluate whether use of a rapid phenotypic ast improves clinical outcomes compared to use of soc ast methods in clinical settings with high resistance rates.


Eligibility criteria:
inclusion criteria: 1. positive blood culture with gram stain showing gnb 2. hospitalized at the time of gram stain result 3. enrolled within 16 hours of blood culture positivity exclusion criteria: 1. positive blood culture for gnb within the prior 7 days (if known at the time of gram stain result) 2. deceased at the time of gram stain result 3. gram-positive bacilli, gram-positive cocci, gram-negative cocci, yeast, fungi, or multiple morphologies of gnb detected on gram stain of blood culture 4. previous enrollment in this study
effect of terlipressinum on the portal vein pressure of patients with liver tumor after liver resection

Conditions: Portal Vein Pressure

Summary: in this study, investigators aim to screen out the patients with portal hypertension by monitoring intraoperative pvp, and to decide the effect of terlipressinum on the portal pressure after liver resection.

liver resection is a common treatment for liver tumors. but the incidence of postoperative liver failure after hepatectomy is as high as 9-18.6%, which results in relatively high mortality rate . portal hypertension is considered as a contraindication for hepatectomy according to the guidelines of the european society of hepatology and the american society of hepatology. recent studies found that patients with portal hypertension were more likely to have persistent liver failure and shorter long-term survival after liver resection operation, compared to patients without portal hypertension. most of liver cancer patients in china have disease backgroud including chronic hepatitis and cirrhosis. among liver cancer patients, of which function is child a or b and have indication for liver resection, 25% of them have portal hypertension.

Eligibility criteria:
inclusion criteria: 1. patients who receives liver resection. 2. pvp is more than 12mmhg in 5 minutes after liver resection. exclusion criteria: 1. age: \ 75; 2. portal vein tumor thrombus is confirmed by preoperative assays; 3. obstruction of biliary tract; 4. active hepatitis; 5. previous history of myocardial infarction; 6. previous history of chronic kidney disease; 7. severe arrhythmia; 8. any other contraindications of the terlipressinum.

Keywords: terlipressinum portal vein pressure liver tumor resection
effects of intranasal oxytocin on cigarette smoking

Conditions: Nicotine Dependence; Tobacco Smoking

Summary: socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural processes that encode, interpret, and respond to socially and emotionally relevant stimuli) have been implicated in tobacco smoking and relapse, however this potential target for medication development has not been systematically examined. evidence from animal and human laboratories indicate that administration of intranasal oxytocin enhances socioemotional processing and may be efficacious for the treatment of drug addiction, including nicotine dependence. in order to evaluate the potential efficacy of intranasal oxytocin for smoking cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular smokers following overnight abstinence.


Eligibility criteria:
inclusion criteria: * ages 18-40 * smoke \>= 10 cig/day for the past year * english fluency exclusion criteria: * current dsm-5 substance use disorder, excluding nicotine dependence (to minimize alcohol or drug withdrawal symptoms during the study sessions) * any medical condition that would increase risk for study participation (such as sinus infection or other condition blocking access to the olfactory epithelium) * women who are pregnant or nursing * current use of psychiatric medication * breath carbon monoxide (co) levels \< 10ppm measured during study intake (to exclude individuals who overreport smoking in order to participate in the study) * planning to quit or reduce smoking in the next 30 days * current regular use of other nicotine products